CSMS 48653470PGAinformational

Food and Drug Administration (FDA) Revoking Emergency Use Authorizations (EAUs): Non-NIOSH Respirators, Decontamination/Bioburden Reduction Systems

Published Jul 1, 2021

Summary

FDA is revoking Emergency Use Authorizations for non-NIOSH-approved disposable respirators (effective July 6, 2021) and for decontamination/bioburden reduction systems (effective June 30, 2021), meaning these products will no longer be authorized for emergency use in health care settings. The notice provides background and points importers to FDA resources and contacts for questions.

Summary is machine-generated at the linking layer for discovery only. Refer to the source bulletin for authoritative guidance.

CSMS 48653470 · full bulletin